USDA said to approve company’s BSE test

Doreen Muzzi | Mar 30, 2004

A California company says it has received USDA approval for its product to test cattle for Bovine Spongiform Encephalopathy, also known as BSE or mad cow disease.

Bio-Rad Laboratories, Inc. says that USDA has licensed its rapid TeSeE test used for the detection of BSE for use in the National Veterinary Service Laboratories in Ames, Iowa and all network laboratories. The company estimates its test kit will be used to screen as many as 400,000 animals over the next 12 to 18 months.

In mid-March, Agriculture Secretary Ann M. Veneman said the United States would step up its surveillance program for Bovine Spongiform Encephalopathy, testing as many cattle as possible in the high-risk population and a sampling of presumed low-risk cattle over a period of 12 to 18 months.

To help it reach that goal, Veneman transferred $70 million from USDA’s Commodity Credit Corp. to fund the enhanced testing program.

“We are committed to ensuring that a robust U.S. surveillance program continues in this country,” the secretary said. “This one-time extensive surveillance plan reflects the recommendation of the international scientific review panel.”

The enhanced disease surveillance program could translate into coveted government contracts with millions to the makers of BSE testing kits.

"We are pleased that our test has met the stringent requirements of the USDA qualification process,” said Brad Crutchfield, Bio-Rad's vice president of Life Science. “Bio-Rad has extensive experience working with more than 500 labs in 25 countries around the world that screen for BSE. We are well prepared to provide the USDA with the same high level of support that our other customers receive."

Referred to as an enzyme-linked immunosorbent assay, the company’s kit is used for detecting transmissible spongiform encephalopathies, or TSEs. The test detects the presence of the resistant form of prion protein, or PrPres, linked to BSE and can identify these prions at extremely low levels. This capability to find very low levels of prions helps assure that BSE infected animals do not go undetected, and it can produce results in just four hours, the company says.

The BSE testing process includes identification of the abnormal, or resistant prion protein, which is the pathology marker identified in post-mortem bovine tissue samples. This abnormal protein, which is present in an animal’s central nervous system, is particularly concentrated in the area of the brain stem. Tissue sampling is easily handled through the occipital foramen, and followed by screening of the sample using common laboratory techniques listed above.

"The test's speed, ease-of-use, high degree of sensitivity and accuracy have placed it in the highest scientific regard and will aid in USDA's efforts to conduct a reliable and highly effective surveillance program," says Crutchfield.

Bio-Rad’s BSE test received validation from the European Commission, the governing body of the European Union, in July 1999, and the company began selling it in Europe at the end of 2000. Since then, the company has sold millions of test kits throughout the Continent and Japan.